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The aim of the study is to evaluate the potential of a spermidine-based topical gel as an adjuvant to non-surgical treatment of peri-implant mucositis. After a meticulous selection, patients will be randomly assigned to Test (spermidine gel + non-surgical debridement) or Control group (non-surgical debridement).
Following the recording of the clinical parameters (BoP, FMPS, FMBS, PD), mechanical therapy (NSMD) will be performed in the Test group (spermidine gel) by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle. Control group will instead be treated only through the NSMD.
Finally, after 3 months the clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again and the final evaluation will be performed. Data analysis will be performed using statistical software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spermidine Group | Experimental | Mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle. |
|
| NSMD Group | Active Comparator | Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spermidine gel | Procedure | First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of BoP (+/-) | Bleeding on periodontal probing | baseline, 1 and 3 months after periodontal therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Full-mouth Plaque Score (FMPS; %) | Percentage of all sites exhibiting plaque | baseline, 1 and 3 months after periodontal therapy |
| Change of Full-mouth Bleeding Score (FMBS; %) | Percentage of all sites exhibiting bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Ramaglia | Contact | +393476912911 | luca.ramaglia@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Recruiting | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39304548 | Derived | Iorio-Siciliano V, Marasca D, Mauriello L, Vaia E, Stratul SI, Ramaglia L. Treatment of peri-implant mucositis using spermidine and calcium chloride as local adjunctive delivery to non-surgical mechanical debridement: a double-blind randomized controlled clinical trial. Clin Oral Investig. 2024 Sep 21;28(10):537. doi: 10.1007/s00784-024-05924-8. |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with spermidine gel + non-surgical debridement (NSMD) in Test group and with NSMD alone in Control group. All clinical parameters will be recorded at baseline, 1 and 3 months.
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All patients are not masked with respect to test and control procedures, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
| NSMD | Procedure | Only mechanical debridement with curettes and scaler peek tips |
|
| baseline, 1 and 3 months after periodontal therapy |
| Change of Probing Depth (PD; millimeters) | Distance from the gingival margin to the bottom of the peri-implant pocket | baseline, 1 and 3 months after periodontal therapy |